Electrically-insulative hinge for electrosurgical jaw assembly, bipolar forceps including same, and methods of jaw-assembly alignment using fastened electrically-insulative hinge

ABSTRACT

An end effector assembly suitable for use with a forceps includes opposing first and second jaw members pivotably mounted with respect to one another. The first jaw member includes one or more pivot holes defined therein configured to receive a portion of a pivot pin therein. The end effector assembly also includes an electrically-insulative hinge configured to electrically isolate the first and second jaw members from one another including one or more pivot-hole locators having an aperture defined therein. The electrically-insulative hinge is attached to the first jaw member such that the one or more pivot-hole locators align with the one or more pivot holes of the second jaw member.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/080,383, filed Apr. 5, 2011, the entire contents of which is herebyincorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to joints and hinges used to connectmovable components of an electrosurgical instrument and, moreparticularly, to an electrically-insulative hinge for use in anelectrosurgical jaw assembly, a bipolar forceps including anelectrically-insulative hinge, and methods of jaw-assembly alignmentusing a fastened electrically-insulative hinge.

2. Discussion of Related Art

Electrosurgical instruments, such as electrosurgical forceps, havebecome widely used by surgeons. Electrosurgery involves application ofhigh-frequency electrical current to a surgical site to cut, ablate,coagulate, cauterize or seal tissue.

The basic purpose of both monopolar and bipolar electrosurgery is toproduce heat to achieve the desired tissue/clinical effect. In monopolarelectrosurgery, devices use an instrument with a single, activeelectrode to deliver energy from an electrosurgical generator to tissue,and a patient return electrode or pad that is attached externally to thepatient (e.g., a plate positioned on the patient's thigh or back) as themeans to complete the electrical circuit between the electrosurgicalgenerator and the patient. When the electrosurgical energy is applied,the energy travels from the active electrode, to the surgical site,through the patient and to the return electrode.

In bipolar electrosurgery, the electrosurgical device includes twoelectrodes that are located in proximity to one another for theapplication of current between their surfaces. Bipolar electrosurgicalcurrent travels from one electrode, through the intervening tissue tothe other electrode to complete the electrical circuit. Bipolarinstruments generally include end effectors, such as grippers, cutters,forceps, dissectors and the like.

Bipolar electrosurgical forceps utilize two generally opposingelectrodes that are operably associated with the inner opposing surfacesof end effectors and that are both electrically coupled to anelectrosurgical generator. Each electrode is charged to a differentelectric potential. By utilizing an electrosurgical forceps, a surgeoncan utilize both clamping action and electrosurgical energy tocauterize, coagulate/desiccate and/or cut tissue and/or simply reduce orslow bleeding by controlling the intensity, frequency and duration ofthe electrosurgical energy applied to the tissue.

Typically, joints and hinges for use in electrosurgical instruments toconnect movable components are formed from an electrically-insulativematerial to prevent electrical shorting between component parts and/orprevent the formation of alternate current paths through the instrument.As such, instrument designers have manufactured electrosurgicalinstruments that involve complex, rotating hinge configurations toisolate, insulate and/or control the electrosurgical active areas of theinstrument.

Traditional metal hinge configurations generally include multiple,independent sub-assemblies. Typically, the sub-assemblies are overmoldedwith plastic material having high bond strength. These separatelyovermolded sub-assemblies are mechanically integrated and arranged in aseries of manufacturing steps that often require tightly controlled,time-consuming processes to achieve proper jaw alignment. Additionalsteps are often undertaken to control other parameters associated withthe rotational movement about the hinge, e.g., friction, torque, etc.

SUMMARY

A continuing need exists for a simple and effectiveelectrically-insulative hinge that can be readily integrated into themanufacturing process to electrically isolate the movable components ofan electrosurgical instrument. Further need exists for the developmentof a manufacturing process that effectively fabricates anelectrosurgical instrument including an electrically-insulative hingethat electrically isolates and structurally integrates theelectrically-active components of the instrument and results in theformation of a reliable instrument that meets specific tolerancerequirements for proper jaw alignment and/or gap distances.

The present disclosure relates to an end effector assembly suitable foruse with a forceps. The end effector assembly includes opposing firstand second jaw members pivotably mounted with respect to one another.The first jaw member includes one or more pivot holes defined thereinconfigured to receive a portion of a pivot pin therein. The end effectorassembly also includes an electrically-insulative hinge configured toelectrically isolate the first and second jaw members from one anotherincluding one or more pivot-hole locators defined therein. Theelectrically-insulative hinge is attached to the second jaw member suchthat the one or more pivot-hole locators aligns with the one or morepivot holes defined in the first jaw member.

The present disclosure also relates to a bipolar forceps including ahousing, a shaft extending from the housing and including a distal endconfigured to support an end effector assembly. The end effectorassembly includes opposing jaw members pivotably mounted with respect toone another, each of the jaw members including a sealing surfaceassociated therewith. The jaw members are moveable from a first positionin spaced relation relative to one another to one or more subsequentpositions wherein the sealing surfaces cooperate to grasp tissuetherebetween. The end effector assembly also includes anelectrically-insulative hinge configured to electrically isolate the jawmembers from one another including one or more pivot-hole locators eachhaving an aperture defined therein. The electrically-insulative hinge isattached to one of the jaw members such that the aperture of each of theone or more pivot-hole locators aligns with a pivot hole defined in theopposing jaw member, wherein the electrically-insulative hinge isconfigured to electrically isolate the jaw members from one another.

The present disclosure also relates to a method of manufacturing an endeffector assembly including the initial steps of providing a first jawmember and providing a second jaw member including one or more pivotholes defined therethrough. The method also includes the steps ofproviding an electrically-insulative hinge including one or morepivot-hole locators defined therein, attaching theelectrically-insulative hinge to the first jaw member such that the oneor more pivot-hole locators align with the one or more pivot holes ofthe second jaw member, and pinning the first and second jaw members viathe one or more pivot-hole locators and the one or more pivot holes suchthat the first and second jaw members are pivotably mounted with respectto one another.

The present disclosure also relates to a method of manufacturing an endeffector assembly including the initial steps of providing a first jawmember including a first pivot hole defined therethrough and providing asecond jaw member including a second pivot hole defined therethrough.The method also includes the steps of providing anelectrically-insulative hinge including at least one pivot-hole locatordefined therein, attaching the electrically-insulative hinge to thefirst jaw member such that the at least one pivot-hole locator alignswith the first pivot hole, providing a fixture configured to releaseablyhold the first jaw member in contact with the second jaw member,providing a pivot pin, coupling the fixture to the first and second jawmembers, and inserting the pivot pin through the at least one pivot-holelocator into the first and second pivot holes such that the first andsecond jaw members are pivotably mounted with respect to one another.

BRIEF DESCRIPTION OF THE DRAWINGS

Objects and features of the presently-disclosed electrically-insulativehinge for use in an electrosurgical jaw assembly, a bipolar forcepsincluding an electrically-insulative hinge, and methods of jaw-assemblyalignment using a fastened electrically-insulative hinge will becomeapparent to those of ordinary skill in the art when descriptions ofvarious embodiments thereof are read with reference to the accompanyingdrawings, of which:

FIG. 1 is a left, side view of an endoscopic bipolar forceps showing ahousing, a rotatable member, a shaft and an end effector assemblyaccording to an embodiment of the present disclosure;

FIG. 2 is an enlarged, perspective view of the shaft and lower jawmember of the forceps shown in FIG. 1 with parts separated according toan embodiment of the present disclosure;

FIG. 3 is an enlarged, cross-sectional view of the indicated area ofdetail of FIG. 2 according to an embodiment of the present disclosure;

FIG. 4 is a schematic diagram of the end effector assembly with anelectrically-insulative hinge according to an embodiment of the presentdisclosure;

FIG. 5 is a cross-sectional view taken along the lines “I-I” of FIG. 4illustrating the jaw members, pivot pin and electrically-insulativehinge according to an embodiment of the present disclosure;

FIG. 6 is a cross-sectional view illustrating another embodiment of anend effector assembly including the electrically-insulative hinge ofFIG. 4 in accordance with the present disclosure;

FIG. 7 is a schematic diagram showing a fixture for releaseably holdingthe end effector assembly of FIG. 6, such as during a fastening process,according to an embodiment of the present disclosure;

FIG. 8 is a schematic diagram of an embodiment of a bilateral endeffector assembly with an electrically-insulative hinge in accordancewith the present disclosure;

FIG. 9 is a side-view schematic diagram of the end effector assembly ofFIG. 8 illustrating the upper jaw member, pivot pin andelectrically-insulative hinge according to an embodiment of the presentdisclosure;

FIG. 10 is an enlarged, left perspective view of the end effectorassembly of FIG. 1 shown with the jaw members in an open configurationaccording to an embodiment of the present disclosure;

FIG. 11 is an enlarged, bottom, left perspective view of the endeffector assembly of FIG. 10 according to an embodiment of the presentdisclosure;

FIG. 12 is an enlarged, top, left perspective view of the end effectorassembly of FIG. 1 with parts separated according to an embodiment ofthe present disclosure;

FIG. 13 is an enlarged, cross-sectional view of a portion of the forcepsshown in FIG. 1 according to an embodiment of the present disclosure;

FIG. 14 is an enlarged, rear perspective view of the end effectorassembly of FIG. 1 shown grasping tissue;

FIG. 15 is an enlarged, cross-sectional view of a tissue seal;

FIG. 16 is a perspective view showing the forceps of the presentdisclosure utilized with a cannula;

FIG. 17 is a flowchart illustrating a method of manufacturing an endeffector assembly according to an embodiment of the present disclosure;

FIG. 18 is a flowchart illustrating a method of manufacturing an endeffector assembly according to another embodiment of the presentdisclosure; and

FIG. 19 is a flowchart illustrating a method of manufacturing an endeffector assembly according to yet another embodiment of the presentdisclosure.

DETAILED DESCRIPTION

Hereinafter, embodiments of an electrically-insulative hinge for use inan electrosurgical jaw assembly, a bipolar forceps including anelectrically-insulative hinge, and methods of jaw-assembly alignmentusing a fastened electrically-insulative hinge of the present disclosureare described with reference to the accompanying drawings. Likereference numerals may refer to similar or identical elements throughoutthe description of the figures. As shown in the drawings and as used inthis description, and as is traditional when referring to relativepositioning on an object, the term “proximal” refers to that portion ofthe apparatus, or component thereof, closer to the user and the term“distal” refers to that portion of the apparatus, or component thereof,farther from the user.

This description may use the phrases “in an embodiment,” “inembodiments,” “in some embodiments,” or “in other embodiments,” whichmay each refer to one or more of the same or different embodiments inaccordance with the present disclosure. For the purposes of thisdescription, a phrase in the form “A/B” means A or B. For the purposesof the description, a phrase in the form “A and/or B” means “(A), (B),or (A and B)”. For the purposes of this description, a phrase in theform “at least one of A, B, or C” means “(A), (B), (C), (A and B), (Aand C), (B and C), or (A, B and C)”.

Electromagnetic energy is generally classified by increasing energy ordecreasing wavelength into radio waves, microwaves, infrared, visiblelight, ultraviolet, X-rays and gamma-rays. As it is used in thisdescription, “microwave” generally refers to electromagnetic waves inthe frequency range of 300 megahertz (MHz) (3×10⁸ cycles/second) to 300gigahertz (GHz) (3×10¹¹ cycles/second). As it is used in thisdescription, “ablation procedure” generally refers to any ablationprocedure, such as, for example, microwave ablation, radiofrequency (RF)ablation, or microwave or RF ablation-assisted resection. As it is usedin this description, “transmission line” generally refers to anytransmission medium that can be used for the propagation of signals fromone point to another.

Various embodiments of the present disclosure provide a bipolar forcepswith an end effector assembly including opposing jaw members pivotablymounted with respect to one another, and an electrically-insulativehinge fastened to one of the jaw members, wherein theelectrically-insulative hinge is configured to electrically isolate thejaw members from one another. Various embodiments of the presentdisclosure provide methods of manufacturing an end effector assemblyincluding the presently-disclosed electrically-insulative hinge.

Embodiments of the presently-disclosed bipolar forceps may be suitablefor utilization in endoscopic surgical procedures, such as shown in FIG.16, and/or suitable for utilization in open surgical applications.Embodiments of the presently-disclosed bipolar forceps may beimplemented using electromagnetic radiation at microwave frequencies, RFfrequencies or at other frequencies. An electrosurgical system includingthe presently-disclosed endoscopic bipolar forceps operatively coupledto an electrosurgical energy source (e.g., 16 shown in FIG. 1) accordingto various embodiments is designed and configured to operate atfrequencies between about 300 KHz and about 10 GHz.

Although the following description describes the use of an endoscopicbipolar forceps, the teachings of the present disclosure may also applyto a variety of electrosurgical devices that include hinges used toconnect movable components thereof.

In FIG. 1, an embodiment of an endoscopic bipolar forceps 10 is shownfor use with various surgical procedures and generally includes ahousing 20, a handle assembly 30, a rotatable assembly 80, a triggerassembly 70 and an end effector assembly 100 that mutually cooperate tograsp, seal and/or divide tubular vessels and vascular tissue (e.g.,1420 shown in FIGS. 14 through 16). Although FIG. 1 depicts a bipolarforceps 10 for use in connection with endoscopic surgical procedures,the teachings of the present disclosure may also apply to moretraditional open surgical procedures. For the purposes herein, theforceps 10 is described in terms of an endoscopic instrument; however,it is contemplated that an open version of the forceps may also includethe same or similar operating components and features as describedbelow.

Forceps 10 includes a shaft 12 that has a distal end 16 configured tomechanically engage the end effector assembly 100 and a proximal end 14configured to mechanically engage the housing 20. In some embodiments,the shaft 12 has a length from a proximal side of the handle assembly 30to a distal side of the forceps 10 in a range of about 7 centimeters toabout 44 centimeters.

Details of how the shaft 12 connects to the end effector assembly 100are described in more detail below with respect to FIG. 2. The proximalend 14 of the shaft 12 is received within the housing 20, andconnections relating thereto are disclosed in commonly assigned U.S.Pat. No. 7,150,097 entitled “METHOD OF MANUFACTURING JAW ASSEMBLY FORVESSEL SEALER AND DIVIDER”, commonly assigned U.S. Pat. No. 7,156,846entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS ANDCANNULAS”, commonly assigned U.S. Pat. No. 7,597,693 entitled “VESSELSEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS” and commonlyassigned U.S. Pat. No. 7,771,425 entitled “VESSEL SEALER AND DIVIDERHAVING A VARIABLE JAW CLAMPING MECHANISM”.

Forceps 10 includes an electrosurgical cable 310. Electrosurgical cable310 may be formed from a suitable flexible, semi-rigid or rigid cable,and may connect directly to an electrosurgical power generating source16, e.g., a microwave or RF electrosurgical generator. In someembodiments, the electrosurgical cable 310 connects the forceps 10 to aconnector 17, which further operably connects the instrument 10 to theelectrosurgical power generating source 16. Electrosurgical cable 310may be internally divided into one or more cable leads (e.g., 311 shownin FIG. 12) each of which transmits electrosurgical energy through theirrespective feed paths to the end effector assembly 100.

Electrosurgical power generating source 16 may be any generator suitablefor use with electrosurgical devices, and may be configured to providevarious frequencies of electromagnetic energy. Examples ofelectrosurgical generators that may be suitable for use as a source ofelectrosurgical energy are commercially available under the trademarksFORCE EZ™, FORCE FX™, SURGISTAT™ II, and FORCE TRIAD™ offered byCovidien. Electrosurgical cable 310 may additionally, or alternatively,provide a conduit (not shown) configured to provide coolant fluid from acoolant source (not shown) to one or more components of the forceps 10.Forceps 10 may alternatively be configured as a wireless device orbattery-powered.

End effector assembly 100 may be selectively and releaseably engageablewith the distal end 16 of the shaft 12, and/or the proximal end 14 ofthe shaft 12 may be selectively and releaseably engageable with thehousing 20 and the handle assembly 30. In either of these two instances,the forceps 10 would be considered “partially disposable” or“reposable”, e.g., a new or different end effector assembly 100 (or endeffector assembly 100 and shaft 12) selectively replaces the old endeffector assembly 100 as needed. As can be appreciated, some of thepresently-disclosed electrical and/or mechanical connections may have tobe altered to modify the instrument to a reposable forceps.

End effector assembly 100 generally includes a pair of opposing jawmembers 110 and 120 pivotably mounted with respect to one another. Endeffector assembly 100 includes an electrically-insulative hinge 450(shown in FIGS. 12 and 13), which is described in more detail later inthis disclosure, configured to electrically isolate the jaw members fromone another. Electrically-insulative hinge 450 can be used to align thejaw members 110 and 120 during assembly of the end effector assembly100, such as shown in FIG. 7. End effector assembly 100 is designed as aunilateral assembly, i.e., the end effector assembly 100 includes astationary or fixed jaw member 120 mounted in fixed relation to theshaft 12 and a pivoting jaw member 110 mounted about a pivot pin 103(shown in FIGS. 10 through 13) coupled to the stationary jaw member 120.Alternatively, the forceps 10 may include a bilateral jaw assembly,i.e., both jaw members move relative to one another. A reciprocatingsleeve 60 (shown in FIGS. 11 through 14) is slidingly disposed withinthe shaft 12. Pulling the sleeve 60 proximally closes the jaw members110 and 120 about tissue grasped therebetween, and pushing the sleeve 60distally opens the jaw members 110 and 120. Sleeve 60 is remotelyoperable by a drive assembly (not shown).

As shown in FIGS. 10 through 13, the pivoting jaw member 110 includes adetent or protrusion 117 that extends from the pivoting jaw member 110through an aperture 62 (FIGS. 11 and 13) disposed within thereciprocating sleeve 60. As best shown in FIG. 11, the protrusion 117 isconfigured to matingly engage the aperture 62 of sleeve 60 uponretraction thereof. Pivoting jaw member 110 is actuated by sliding thereciprocating sleeve 60 axially within the shaft 12 such that a distalend of the aperture 62 abuts against the detent 117 on the pivoting jawmember 110. For example, proximal movement of the sleeve 60 engagesdetent 117 to pivot the jaw member 110 to a closed position for graspingpurposes.

As shown in FIG. 1, the end effector assembly 100 is rotatable about alongitudinal axis “A-A” through rotation, either manually or otherwise,of the rotatable assembly 80. Rotatable assembly 80 generally includestwo halves (not shown), which, when assembled about tube 160 (FIGS. 2and 3), form a generally circular rotatable member 82. Rotatableassembly 80, or portions thereof, may be configured to house a driveassembly (not shown) and/or a knife assembly 180 (shown in FIG. 13), orcomponents thereof. Examples of rotatable assembly embodiments, driveassembly embodiments, and knife assembly embodiments of the forceps 10are described in the above-mentioned, commonly-assigned U.S. Pat. Nos.7,150,097, 7,156,846, 7,597,693 and 7,771,425.

Handle assembly 30 includes a fixed handle 50 and a movable handle 40.In some embodiments, the fixed handle 50 is integrally associated withthe housing 20, and the handle 40 is selectively movable relative to thefixed handle 50. Movable handle 40 of the handle assembly 30 isultimately connected to the drive assembly (not shown) and mechanicallycooperate to impart movement of the jaw members 110 and 120 from an openposition, wherein the jaw members 110 and 120 are disposed in spacedrelation relative to one another, to a clamping or closed position,wherein the jaw members 110 and 120 cooperate to grasp tissue (e.g.,1420 shown in FIG. 14) therebetween. Examples of handle assemblyembodiments of the forceps 10 are described in the above-mentioned,commonly-assigned U.S. Pat. Nos. 7,150,097, 7,156,846, 7,597,693 and7,771,425.

Forceps 10 includes a switch 200 configured to permit the user toselectively activate the forceps 10 in a variety of differentorientations, i.e., multi-oriented activation. As can be appreciated,this simplifies activation. When the switch 200 is depressed,electrosurgical energy is transferred through one or more leads (e.g.,311 shown in FIGS. 10, 12 and 13) to the jaw members 110 and 120. Switch200 may be disposed on another part of the forceps 10 (e.g., the fixedhandle 50, rotatable member 82, etc.) or another location on the housingassembly 20.

FIG. 4 shows a schematic of an end effector assembly 400 that includesan electrically-insulative hinge 450 according to an embodiment of thepresent disclosure. End effector assembly 400 (also referred to hereinas a “jaw assembly”) generally includes a pair of opposing jaw members410 and 420. Jaw members 410 and 420 are pivotably mounted with respectto one another such that jaw member 410 pivots in a unilateral fashionfrom an open position to a closed position for grasping and manipulatingtissue. Jaw members 410 and 420 shown in FIG. 4 are similar to the jawmembers 110 and 120 of FIG. 1, respectively, and further descriptionthereof is omitted in the interests of brevity.

As best shown in FIG. 7, the electrically-insulative hinge 450 isconfigured with one or more pivot-hole locators 454 to facilitate properalignment of the jaw members 410 and 420 during assembly of the endeffector assembly 400. Electrically-insulative hinge 450 is configuredto electrically isolate the jaw members 410 and 420 from one another,and may be bonded or otherwise securely attached to either one of thejaw members. Electrically-insulative hinge 450 may be attached to themoveable jaw member 410 or the fixed jaw member 420 using any suitablematerial or bonding process.

In the embodiment shown in FIGS. 4 and 5, the electrically-insulativehinge 450 is attached to the moveable jaw member 410, e.g., using anadhesive material 415. Alternatively, the electrically-insulative hinge450 may be attached to the fixed jaw member (e.g., 620, as shown in FIG.6). In some embodiments, as shown in FIG. 5, the fixed jaw member 420and the electrically-insulative hinge 450 affixed to the moveable jawmember 410 are spaced apart by a gap 416, e.g., to reduce frictionand/or wear.

During use of the jaw assembly 400, the electrically-insulative hinge450 maintains electrical isolation of the jaw members 410 and 420,permitting energy potential to flow through the tissue being treatedbefore returning through the opposing jaw. For example, when the jawmembers 410 and 420 are electrically isolated from one another,electrosurgical energy can be effectively transferred through tissue1420 to form seal 1450 as shown in FIG. 15.

In the embodiment shown in FIGS. 4 and 5, the unilateral jaw assembly400 includes the electrically-insulative hinge 450 and a pivot pin 403connecting the jaw members 410 and 420 at their rotation point, allowingthe movable jaw member 410 to rotate relative to the fixed jaw member420. As cooperatively shown in FIGS. 4 and 5, the pivot pin 403 passesthrough the pin slot or opening 419 defined in the moveable jaw member410 and is received by the pivot holes defined in the fixed jaw member420 (e.g., similar to the pivot holes 101 a, 101 b defined in the fixedjaw member 120 shown in FIG. 12) and the apertures 451 (FIG. 12) definedin the pivot-hole locators 454 of the electrically-insulative hinge 450such that the jaw members 410 and 420 are pivotably mounted with respectto one another. Alternatively, wherein both jaw members are movable, abilateral end effector assembly (e.g., bilateral end effector assembly800 shown in FIG. 8) includes an electrically-insulative hinge (e.g.,850 shown in FIG. 8) configured to provide electrical isolation of thejaw members.

As shown in FIGS. 5, 6 and 8, the presently-disclosed jaw assemblies andelectrically-insulative hinge embodiments allow a pivot pin (e.g., 403shown in FIG. 5, 603 shown in FIG. 6, and 803 shown in FIG. 8) to beconnected to one jaw member (e.g., 420 shown in FIG. 5, 610 shown inFIG. 6, and 810 shown in FIG. 8) and to the electrically-insulativehinge (e.g., 450 shown in FIGS. 5 and 6, and 850 shown in FIG. 8) thatis bonded or otherwise attached to the opposing jaw member. In eitherunilateral or bilateral end effector embodiments, by connecting thepivot pin, which may be formed of an electrically-conductive material,to one jaw member and not to the other jaw member but, instead, to theelectrically-insulative hinge, the pivot pin will not defeat theelectrical isolation of the jaw members.

As cooperatively shown in FIGS. 4 and 7, electrically-insulative hinge450 includes a generally U-shaped body member 452 and two end portions453 a and 453 b disposed at the opposite ends of the body member 452.The shape and size of the body member 452 and end portions 453 a and 453b, which are described in more detail below, may be varied from theconfiguration depicted in FIGS. 4 through 7.

Electrically-insulative hinge 450 is configured with one or morepivot-hole locators 454, e.g., defined by the end portions 453 a and/or453 b. In some embodiments, each of the end portions 453 a and 453 bincludes an aperture 451 defined therein. Alternatively, only one of theend portions 453 a or 453 b includes an aperture 451 defined therein.Aperture 451 is configured to receive a portion of a pivot pin 403therein. Electrically-insulative hinge 450 is formed from a suitableelectrically-insulative material. Examples of electrically-insulativematerials that may be suitable for forming the electrically-insulativehinge 450 include without limitation plastics, ceramic, glass or othernon-conductive materials with desired properties.Electrically-insulative hinge 450 may be fastened to either one of thejaws by any suitable process including without limitation adhesivebonding, soldering, brazing, overmolding, mechanical interlock, snaps,bent tabs, screws or other mechanical fasteners, etc.

FIG. 6 shows a unilateral jaw assembly 600 that includes theelectrically-insulative hinge 450, a pivot pin 603, and jaw members 610and 620. In the embodiment shown in FIG. 6, the electrically-insulativehinge 450 is attached to the fixed jaw member 620, e.g., using anadhesive material 613. In some embodiments, the moveable jaw member 610and the electrically-insulative hinge 450 that is attached to the fixedjaw member 620 are spaced apart by a gap 616, e.g., to reduce frictionand/or wear.

FIG. 7 shows a schematic of a fixture 780 configured to releaseably holdthe end effector assembly 600 of FIG. 6, such as during a fasteningprocess, according to an embodiment of the present disclosure. Fixture780 is configured to hold the jaw members 610 and 620 in properalignment while the electrically-insulative hinge 450 is fastened and/orcured to the moveable jaw member 610 or the fixed jaw member 620. Insome embodiments, the jaw members 610 and 620 are self-aligned bypre-assembling the jaw components including the jaw members 610 and 620,the electrically-insulative hinge 450 and the pivot pin 603. Anyremaining degrees of freedom are then constrained by the holding fixture780 until the bond between the electrically-insulative hinge 450 and thefixed jaw member 620 (shown in FIG. 6) or the bond between theelectrically-insulative hinge 450 and the moveable jaw member 610 iscompleted. In the embodiment shown in FIG. 7, the fixture 780 serves tohold the sealing surface of the jaw member 610 directly against thesealing surface of the jaw member 620 with desired jaw gap controlled bygap features on the jaw members 610, 620 and/or with shims used duringassembly, which may be a critical alignment, while the bond is made.When the bonding process is completed, the holding fixture 780 may beremoved from the jaw assembly 600. It will be appreciated thatadditional manufacturing steps may be undertaken after the bondingprocess is completed, prior to the release of the jaw assembly 600 fromthe fixture 780. In some embodiments, after the bonding process iscompleted, the pivot pin 603 may be removed and the jaws separated, ifdesired, for assembly or further processing.

In some embodiments, the fixture 780 includes a shaft 782, a first legmember 783 disposed at a first end 781 a of the shaft 782, and a secondleg member 785 disposed at a second end 781 b of the shaft 782. Firstleg member 783 and the second leg member 785 may extend in asubstantially perpendicular direction away from the shaft 782, such thatthe fixture 780 may have a generally U-like shape. In some embodiments,the shaft 782, the first leg member 783 and the second leg member 785are integrally formed. In some embodiments, the first leg member 783includes a first tip portion 784 and the second leg member 785 includesa second tip portion 786. In some embodiments, the shaft 782, the firstleg member 783, the first tip portion 784, the second leg member 785 andthe second tip portion 786 may be configured such that the fixture 780has a generally C-like shape. Fixture 780 could be formed in a varietyof shapes suitable to constrain the jaw members adequately duringcompletion of the bonding process. Fixture 780 may be made from metal,plastic, ceramic and/or other suitable materials with desiredproperties, e.g., machinability, flexibility, moldability, temperatureresistance, chemical resistance, etc. Fixture 780 and/or the jaw membersmay include features to enable quick, accurate, secure and reliableholding, including without limitation flats, slots, holes, grooves,recesses, pins, stops or any other suitable features that providesalignment and/or mating engagement of the fixture 780 to the jawmembers. In some embodiments, either one (or both) of the jaw membersmay include one or more grooves or recesses defined therein configuredand disposed to accept or matingly engage with one or more edge portionsor protrusions formed on the first tip portion 784 and/or the second tipportion 786 of the fixture 780.

FIG. 8 shows a bilateral end effector assembly 800 that includes anelectrically-insulative hinge 850 that is configured to provideelectrical isolation of the first and second jaw members 810 and 820.Electrically-insulative hinge 850 is formed from a suitableelectrically-insulative material, and includes an aperture definedtherein. FIG. 9 is a side-view of the end effector assembly 800illustrating the second jaw member 820, pivot pin 803, andelectrically-insulative hinge 850.

In the embodiment shown in FIGS. 8 and 9, the electrically-insulativehinge 850 is bonded or otherwise securely attached to the second jawmember 820, e.g., using an adhesive material 813. Alternatively, theelectrically-insulative hinge 850 may be attached to the first jawmember 810. Electrically-insulative hinge 850 may be attached to thefirst jaw member 810 or the second jaw member 820 using any suitablematerial or bonding process.

As shown in FIG. 8, the pivot pin 803 is received by an aperture definedin the electrically-insulative hinge 850 and a pivot hole defined in thefirst jaw member 810. In some embodiments, the pivot pin 803 is securedby a fastener 804, e.g., a pin, cap, shoulder, rivet, swage, nut, etc.In some embodiments, the first jaw member 810 and theelectrically-insulative hinge 850 that is attached to the second jawmember 820 are spaced apart by a gap 816, e.g., to reduce friction andthereby minimize wear.

As shown in FIGS. 10 and 12, jaw member 110 also includes a jaw housing116 that includes an insulative substrate or insulator 114 and anelectrically-conductive surface 112. Insulator 114 is configured tosecurely engage the electrically-conductive sealing surface 112. Thismay be accomplished by stamping, by overmolding, by overmolding astamped electrically-conductive sealing plate and/or by overmolding ametal injection molded seal plate. For example and as shown in FIG. 12,the electrically-conductive sealing plate 112 includes a series ofupwardly extending flanges 111 a and 111 b that are designed to matinglyengage the insulator 114. Insulator 114 includes a shoe-like interface107 disposed at a distal end thereof which is configured to engage theouter periphery 116 a of the housing 116 in a slip-fit manner. Theshoe-like interface 107 may also be overmolded about the outer peripheryof the jaw 110 during a manufacturing step. Lead 311 terminates withinthe shoe-like interface 107 at the point where the lead 311 electricallyconnects to the sealing plate 112. The movable jaw member 110 isconfigured with a wire channel 113 to guide the cable lead 311 intoelectrical continuity with the sealing plate 112.

As best shown in the exploded view of FIG. 12, jaw members 110 and 120are pivotably mounted with respect to one another such that the jawmember 110 pivots in a unilateral fashion from a first open position toa second closed position for grasping and manipulating tissue 1420(shown in FIG. 14). Fixed jaw member 120 includes a pair of proximal,upwardly extending flanges 125 a and 125 b that define a cavity 121configured to receive the pivot flange 118 of the movable jaw member 110therein. Each of the flanges 125 a and 125 b includes an aperture 101 aand 101 b, respectively, defined therethrough that secures the pivot pin103 on opposite sides of a pin slot or opening 119 disposed within thejaw member 110.

Jaw member 110 includes a pivot flange 118. Protrusion 117 extends fromthe pivot flange 118 and includes an arcuately-shaped inner surface 111configured to matingly engage the aperture 62 of sleeve 60 uponretraction thereof. Pivot flange 118 includes an opening 119 definedtherein that is configured to allow the pivot pin 103 to passtherethrough, e.g., to allow jaw member 110 to rotate relative to jawmember 120 upon retraction of the reciprocating sleeve 60. In someembodiments, the pivot pin 103 mounts to the electrically-insulativehinge 450 through a pair of apertures 451 defined therein and mounts tothe stationary jaw member 120 through a pair of apertures 101 a and 101b disposed within a proximal portion of the jaw member 120.

Jaw member 120 fixes to the end of a rotatable tube 160 (shown in FIGS.2 and 3) which is part of the rotatable assembly 80 such that rotationof the tube 160 will impart rotation to the end effector assembly 100.As shown in FIG. 2, the distal end of the tube 160 is generally C-shapedto include two upwardly extending flanges 162 a and 162 b that define acavity 165 for receiving the proximal end of the fixed jaw member 120inclusive of C-shaped cuff 170 and slide pin 171. The tube cavity 165retains and secures the jaw member 120 in a friction-fit manner;however, the jaw member 120 may be welded to the tube 160 depending upona particular purpose. Tube 160 also includes an inner cavity 169 (shownin FIG. 3) defined therethrough that reciprocates the knife assembly 180upon distal activation thereof and an elongated guide rail 163 thatguides the knife assembly 140 during distal activation. The proximal endof tube 160 includes a laterally-oriented slot 168 that is designed tointerface with the rotating assembly 80, as described in theabove-mentioned, commonly-assigned U.S. Pat. Nos. 7,150,097, 7,156,846,7,597,693 and 7,771,425.

Jaw member 120 includes a rear C-shaped cuff 170 having a slot 177defined therein which is configured to receive a slide pin 171. Slidepin 171 includes a slide rail 176 that extends substantially the lengththereof, configured to slide into friction-fit engagement within slot177. A pair of chamfered plates 172 a and 172 b extends generallyradially from the slide rail 176 and include a radius that issubstantially the same radius as the outer periphery of the rotatabletube 160 such that the shaft 12 can encompass each of the same uponassembly. The chamfered plates 172 a and 172 b also form a wire channel175 that is configured to guide the cable lead 311 from the tube 160 andinto the movable jaw member 110 (see FIG. 12). Lead 311 carries a firstelectrical potential to movable jaw 110. The electrically-conductivesurface 112 and the insulator 114, when assembled, include alongitudinally-oriented channel 115 a defined therethrough forreciprocation of the knife blade 185.

Jaw member 120 includes similar elements to jaw member 110 such as jawhousing 126 having an insulator 124 and an electrically-conductivesealing surface 122 that is configured to securely engage the insulator124. Likewise, the electrically-conductive surface 122 and the insulator124, when assembled, include a longitudinally-oriented channel 115 bdefined therethrough for reciprocation of the knife blade 185. Knifechannel 115 (made up of half channels 115 a and 115 b) is blocked whenthe jaws members 110 and 120 are opened and aligned for distalactivation when the jaw members 110 and 120 are closed.

Jaw member 120 is connected to a second electrical potential throughtube 160 which is connected at its proximal end to a lead (not shown).Fixed jaw 120 may include a fuse clip, spring clip or otherelectro-mechanical connection. In some embodiments, at least one jawmember, e.g., 120, includes a stop member 750 that limits the movementof the two opposing jaw members 110 and 120 relative to one another.Stop member embodiments and internal electrical connections of theforceps 10 are described in the above-mentioned, commonly-assigned U.S.Pat. Nos. 7,150,097, 7,156,846, 7,597,693 and 7,771,425. As best shownin FIG. 2, the rotatable tube 160 includes an elongated guide slot 167disposed in an upper portion thereof and configured to carry lead 311therealong.

Proximal movement of the tube 60 engages detent 117 to pivot the jawmember 110 to a closed position. It is understood from FIG. 12 that thejaw member 120 is stationary.

FIG. 14 shows the end effector assembly 100 of FIG. 1 shown graspingtissue 1420. In some embodiments, the end effector assembly 100 mayinclude a gap distance “G” between opposing sealing surfaces 112 duringsealing, e.g., in the range from about 0.001 inches to about 0.006inches. In some embodiments, the end effector assembly 100 includes agap distance “G” between opposing sealing surfaces 112 during sealingthat ranges from about 0.002 to about 0.003 inches. As shown in FIG. 16,the forceps 10 is insertable through a cannula 500 into a patient's bodyfor use during a procedure.

As energy is being selectively transferred to the end effector assembly100, across the jaw members 110 and 120 and through the tissue 1420, atissue seal 1450 forms isolating two tissue halves 1420 a and 1420 b(see FIG. 15). The knife assembly 180 which, when activated via thetrigger assembly 70, progressively and selectively divides the tissue1420 along a tissue plane in a precise manner to divide the tissue 1420into two sealed halves (not shown). Once the tissue 1420 is divided intotissue halves, the jaw members 110 and 120 may be opened byre-initiation or re-grasping of the handle 40.

Hereinafter, methods of manufacturing an end effector assembly aredescribed with reference to FIGS. 17 through 19. It is to be understoodthat the steps of the methods provided herein may be performed incombination and in a different order than presented herein withoutdeparting from the scope of the disclosure.

FIG. 17 is a flowchart illustrating a method of manufacturing an endeffector assembly 100 according to an embodiment of the presentdisclosure that includes a first jaw member 110 and a second jaw member120. In some embodiments, the first and second jaw members 110, 120 areconfigured to be pivotably mounted with respect to one another.

In step 1710, a first jaw member 110 is provided. The first jaw member110 includes a pin slot or opening 119 defined therethrough.

In step 1720, a second jaw member 120 is provided. The second jaw member120 includes one or more pivot holes 101 a, 101 b defined therethrough.

In step 1730, an electrically-insulative hinge 450 is provided that isconfigured to electrically isolate the jaw members from one another. Theelectrically-insulative hinge 450 is formed from a suitableelectrically-insulative material. The electrically-insulative hinge 450includes one or more pivot-hole locators 454 defined therein, and maytake any suitable shape.

In some embodiments, the electrically-insulative hinge 450 includes agenerally U-shaped body member 452 and two end portions 453 a, 453 bdisposed at the opposite ends of the body member 452. One or more of theend portions 453 a, 453 b includes an aperture 451 defined thereinconfigured to receive a portion of a pivot pin 103 therein. In someembodiments the one or more pivot-hole locators 454 are defined by theone or more end portions 453 a, 453 b that include the aperture 451.

In step 1740, the electrically-insulative hinge 450 is attached to thefirst jaw member 110 such that the one or more pivot-hole locators 454align with the one or more pivot holes 101 a, 101 b of the second jawmember 120. The electrically-insulative hinge 450 may be bonded orotherwise securely attached the first jaw member 110 using any suitablematerial or bonding process, e.g., adhesive bonding, soldering, brazing,overmolding, mechanical interlock, snaps, bent tabs, etc.

In step 1750, the first and second jaw members 110, 120 are pinned viathe one or more pivot-hole locators 454 and the one or more pivot holes101 a, 101 b such that the first and second jaw members 110, 120 arepivotably mounted with respect to one another.

FIG. 18 is a flowchart illustrating a method of manufacturing an endeffector assembly 100 according to an embodiment of the presentdisclosure. In step 1810, a first jaw member 110 is provided. The firstjaw member 110 includes a pin slot or opening 119 defined therethrough.

In step 1820, a second jaw member 120 is provided. The second jaw member120 includes one or more pivot holes 101 a, 101 b defined therethrough.

In step 1830, an electrically-insulative hinge 450 is provided that isconfigured to electrically isolate the jaw members from one another. Theelectrically-insulative hinge 450 includes one or more pivot-holelocators 454 having an aperture 451 defined therein.

In step 1840, the electrically-insulative hinge 450 is attached to thefirst jaw member 110 such that the aperture 451 of the one or morepivot-hole locators 454 aligns with the one or more pivot holes 101 a,101 b of the second jaw member 120. The electrically-insulative hinge450 may be bonded or otherwise securely attached the first jaw member110 using any suitable material or bonding process.

In step 1850, a pivot pin 103 is provided. The pivot pin 103 isconfigured to pass through the pin slot or opening 119 and to bereceived by the one or more pivot holes 101 a, 101 b.

In step 1860, the pivot pin 103 is inserted into the one or more pivotholes 101 a, 101 b and the aperture 451 of the one or more pivot-holelocators 454 such that the first and second jaw members 110, 120 arepivotably mounted with respect to one another.

FIG. 19 is a flowchart illustrating a method of manufacturing an endeffector assembly 100 according to an embodiment of the presentdisclosure. In step 1910, a first jaw member 110 is provided. The firstjaw member 110 includes a pin slot or opening 119 defined therethrough.

In step 1920, a second jaw member 120 is provided. The second jaw member120 includes one or more pivot holes 101 a, 101 b defined therethrough.

In step 1930, an electrically-insulative hinge 450 is provided that isconfigured to electrically isolate the jaw members from one another. Theelectrically-insulative hinge 450 includes one or more pivot-holelocators 454 defined therein.

In step 1940, the electrically-insulative hinge 450 is attached to thefirst jaw member 110 such that the one or more pivot-hole locators 454align with the one or more pivot holes 101 a, 101 b of the second jawmember 120. The electrically-insulative hinge 450 may be bonded orotherwise securely attached the first jaw member 110 using any suitablematerial or bonding process.

In step 1950, a holding fixture 780 is provided. The fixture 780 isconfigured to releaseably hold the first jaw member 110 in contact withthe second jaw member 120. In some embodiments, the fixture 780 isconfigured to hold the first and second jaw members 110, 120 in properalignment while the electrically-insulative hinge 450 is fastened and/orcured to the first jaw member 110 (or the second jaw member 120). Insome embodiments, the fixture 780 is configured to hold the sealingsurface 112 of the first jaw member 110 directly against the sealingsurface 122 of the second jaw member 120 in proper alignment while theelectrically-insulative hinge 450 is fastened and/or cured to the firstjaw member 110 (or the second jaw member 120).

In step 1960, a pivot pin 103 is provided. In some embodiments, thepivot pin 103 is configured to pass through the pin slot or opening 119and to be received by the one or more pivot holes 101 a, 101 b.

In step 1970, the fixture 780 is releasably coupled to the first andsecond jaw members 110, 120. In some embodiments, the jaw member 110and/or the jaw member 120 may include one or more grooves or recessesdefined therein configured and disposed to accept or matingly engagewith one or more edge portions or protrusions formed on a first and tipportion 784 and/or a second tip portion 786 of the fixture 780.

In step 1980, the pivot pin 103 is inserted into the one or more pivotholes 101 a, 101 b and the one or more pivot-hole locators 454 such thatthe first and second jaw members 110, 120 are pivotably mounted withrespect to one another.

In some embodiments, after the pivot pin 103 is inserted into the one ormore pivot holes 101 a, 101 b and the one or more pivot-hole locators454, in step 1980, and after the bond between theelectrically-insulative hinge 450 and the first jaw member 110 iscompleted, the first and second jaw members 110, 120 are released fromthe fixture 780, in step 1990. It will be appreciated that additionalmanufacturing steps may be undertaken after the step 1980, prior to therelease of the first and second jaw members 110, 120 from the fixture780.

The presently-disclosed bipolar forceps is capable of directing energyinto tissue, and may be suitable for use in a variety of procedures andoperations. The above-described bipolar forceps embodiments may utilizeboth mechanical clamping action and electrical energy to effecthemostasis by heating tissue and blood vessels to coagulate, cauterize,cut and/or seal tissue. The jaw assemblies may be either unilateral orbilateral. The above-described bipolar forceps embodiments may besuitable for utilization with endoscopic surgical procedures and/orhand-assisted, endoscopic and laparoscopic surgical procedures. Theabove-described bipolar forceps embodiments may be suitable forutilization in open surgical applications.

Although embodiments have been described in detail with reference to theaccompanying drawings for the purpose of illustration and description,it is to be understood that the inventive processes and apparatus arenot to be construed as limited thereby. It will be apparent to those ofordinary skill in the art that various modifications to the foregoingembodiments may be made without departing from the scope of thedisclosure.

What is claimed is:
 1. An end effector assembly for a forceps, the endeffector assembly comprising: a first jaw member including a first pivotpin opening defined therein and having a first sealing surface; a secondjaw member including a second pivot pin opening defined therein andhaving a second sealing surface opposing the first sealing surface; apivot pin configured to pass through the first and second pivot pinopenings to pivotably couple the first and second jaw members to oneanother about the pivot pin; and a hinge positioned between the firstjaw member and the second jaw member configured to electrically isolatethe first and second jaw members from one another, the hinge including aU-shaped body disposed in a plane parallel to at least one of the firstand second sealing surfaces and including first and second end portionsdisposed at opposite ends of the U-shaped body, the first and second endportions each defining a pivot hole that receives the pivot pin.
 2. Theend effector assembly according to claim 1, wherein the pivot pin isformed of an electrically conductive material, and wherein the hingeelectrically isolates the pivot pin from at least one of the first andsecond jaw members.
 3. The end effector assembly according to claim 1,wherein the hinge is fastened to the second jaw member.
 4. The endeffector assembly according to claim 3, wherein the hinge is fastened tothe second jaw member by at least one of adhesive bonding, soldering,brazing, overmolding, mechanically interlocking, snapping, screwing, orbending of tabs.
 5. The end effector assembly according to claim 3,wherein the pivot holes of the first and second end portions are alignedwith and disposed on opposite sides of the second pivot pin opening, thepivot pin passing through the pivot holes of the first and second endportions.
 6. The end effector assembly according to claim 5, wherein thepivot holes each have a first diameter and the second pivot pin openinghas a second diameter larger than the first diameter.
 7. The endeffector assembly according to claim 5, wherein the pivot pin is fixedwithin the first pivot pin opening of the first jaw member.
 8. The endeffector assembly according to claim 1, wherein the pivot pin defines apivot axis transverse to a longitudinal axis of the first jaw member anda longitudinal axis of the second jaw member.
 9. The end effectorassembly according to claim 1, wherein the U-shaped body has a proximalbackspan, a first leg extending distally from a first end of thebackspan to the first end portion, and a second leg extending from asecond end of the backspan to the second end portion.
 10. The endeffector assembly according to claim 9, wherein the backspan, the firstleg, and the second leg have a first dimension defined orthogonal to theplane parallel to the at least one of the first and second sealingsurfaces, wherein each of the first and second end portions have asecond dimension defined orthogonal to the plane parallel to the atleast one of the first and second sealing surfaces, and wherein thesecond dimension is greater than the first dimension.
 11. The endeffector assembly according to claim 9, wherein the first end portionextends from the first leg in a direction towards and orthogonal to thefirst and second sealing surfaces, and wherein the second end portionextends from the second leg in a direction towards and orthogonal to thefirst and second sealing surfaces.
 12. The end effector assemblyaccording to claim 1, wherein the first jaw member includes a pair ofproximal flanges that define a cavity therebetween, wherein the secondjaw member includes a pivot flange received within the cavity, andwherein each proximal flange defines a portion of the first pivot pinopening.
 13. The end effector assembly according to claim 12, whereinthe first and second end portions are disposed on opposite sides of thepivot flange and are each disposed between the pivot flange of thesecond jaw member and one of the pair of proximal flanges of the firstjaw member.
 14. The end effector assembly according to claim 13, whereinthe hinge is disposed about a proximal surface of the pivot flange. 15.An end effector assembly for a forceps, the end effector assemblycomprising: a first jaw member having a pair of proximal flangesdefining a cavity therebetween, each proximal flange including a pivotpin opening defined therein; a second jaw member having a proximal pivotflange including a pivot pin opening defined therein, the pivot flangepositioned within the cavity of the first jaw member; a pivot pinconfigured to pass through the pivot pin openings of the first andsecond jaw members to pivotably couple the first and second jaw membersto one another about the pivot pin; and a hinge positioned between thefirst jaw member and the second jaw member configured to electricallyisolate the first and second jaw members from one another, the hingehaving a U-shaped body including first and second end portions disposedat opposite ends of the U-shaped body, the first and second end portionseach defining a pivot hole that receives the pivot pin.
 16. The endeffector assembly according to claim 15, wherein the pivot holes eachhave a first diameter and the pivot pin opening of the second jaw memberhas a second diameter larger than the first diameter.
 17. The endeffector assembly according to claim 15, wherein the pivot pin is fixedwithin the pivot pin opening of the first jaw member.
 18. The endeffector assembly according to claim 15, wherein the hinge is disposedabout a proximal surface of the pivot flange.
 19. A forceps, comprising:a housing; a shaft extending from the housing and including a distalend; and an end effector assembly supported at the distal end of theshaft, the end effector assembly including: a first jaw member includinga first pivot pin opening defined therein and having a first sealingsurface; a second jaw member including a second pivot pin openingdefined therein and having a second sealing surface opposing the firstsealing surface; a pivot pin configured to pass through the first andsecond pivot pin openings to pivotably couple the first and second jawmembers to one another about the pivot pin; and a hinge positionedbetween the first jaw member and the second jaw member configured toelectrically isolate the first and second jaw members from one another,the hinge including a U-shaped body disposed in a plane parallel to atleast one of the first and second sealing surfaces and including firstand second end portions disposed at opposite ends of the U-shaped body,the first and second end portions each defining a pivot hole thatreceives the pivot pin.
 20. The forceps according to claim 19, whereinthe first jaw member is fixed to the distal end of the shaft.